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Respiratory Muscle Function in COPD Exacerbations

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Non-invasive ventilation
Sponsored by
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of COPD according to international guidelines ( GOLD)
  • COPD exacerbation requiring hospitalization
  • Initial blood gases: PaCO2> 50 mm Hg and pH> 7.35.
  • If the patient does not have COPD diagnosis at the time of inclusion, it could be included if the diagnosis is confirmed within three months after the exacerbation.

Exclusion Criteria:

  • Patients with a pH below 7.35
  • Patients with intubation criteria
  • Other chronic respiratory diseases (fibrothorax, cystic fibrosis, significant ribcage alterations)
  • Neuromuscular Diseases
  • Significant associated chronic systemic diseases (severe liver disease, chronic renal failure requiring dialysis, severe heart disease and active neoplasia)
  • COPD exacerbation secondary to pulmonary embolism, pneumonia or pneumothorax
  • Patients in active treatment with CPAP or home ventilation

Sites / Locations

  • Hospital del Mar (Servei de Pneumología)

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard treatment

Standard treatment plus non-invasive ventilation

Arm Description

Standard treatment consists in bronchodilator and parenteral corticosteroids and oxygen therapy.

This arm consists in bronchodilator and parenteral corticosteroids and oxygen therapy plus non-invasive ventilation.

Outcomes

Primary Outcome Measures

Respiratory muscle function.
Measurement of maximal inspiratory pressure and sniff nasal inspiratory pressure using a portable respiratory pressure meter.

Secondary Outcome Measures

Days of hospitalization.
Dyspnea scale questionnaire
Quality of life
Blood gases
Number of hospital readmissions in the next year

Full Information

First Posted
May 27, 2013
Last Updated
May 31, 2013
Sponsor
Parc de Salut Mar
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1. Study Identification

Unique Protocol Identification Number
NCT01869387
Brief Title
Respiratory Muscle Function in COPD Exacerbations
Official Title
Improvement of Respiratory Muscle Function With Noninvasive Ventilation in Exacerbated COPD Patients Presenting Hypercapnic Respiratory Failure Without Acidosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parc de Salut Mar

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
There is evidence that noninvasive mechanical ventilation (NIV) is effective in the treatment of severe exacerbations of COPD presenting respiratory acidosis. The aim of the study is to evaluate the benefit of adding NIV to conventional treatment in patients with COPD exacerbation and hypercapnic respiratory failure without acidosis requiring hospital admission. It is known that NIV improves respiratory mechanics, so the primary outcome will be respiratory muscle function. All patients admitted to the hospital for COPD exacerbation and hypercapnic respiratory failure without acidosis will be included for a period of 12 months. The patients will be randomized into two groups (conventional treatment or conventional treatment plus NIV). Clinical data, blood gases, muscle strength parameters will be collected at the inclusion time and 24h after starting NIV. Quality of life and hospital stay will be measured at discharge. All patients will be followed for a year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
Standard treatment consists in bronchodilator and parenteral corticosteroids and oxygen therapy.
Arm Title
Standard treatment plus non-invasive ventilation
Arm Type
Experimental
Arm Description
This arm consists in bronchodilator and parenteral corticosteroids and oxygen therapy plus non-invasive ventilation.
Intervention Type
Device
Intervention Name(s)
Non-invasive ventilation
Primary Outcome Measure Information:
Title
Respiratory muscle function.
Description
Measurement of maximal inspiratory pressure and sniff nasal inspiratory pressure using a portable respiratory pressure meter.
Time Frame
At baseline, at discharge (average of 8 days), 6 months and one year later.
Secondary Outcome Measure Information:
Title
Days of hospitalization.
Time Frame
At discharge (average of 8 days).
Title
Dyspnea scale questionnaire
Time Frame
At baseline, at discharge, 6 months and one year later.
Title
Quality of life
Time Frame
At baseline, 6 months and one year later.
Title
Blood gases
Time Frame
At baseline and at discharge (average of 8 days).
Title
Number of hospital readmissions in the next year
Time Frame
At one year after discharge (average of 8 days).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of COPD according to international guidelines ( GOLD) COPD exacerbation requiring hospitalization Initial blood gases: PaCO2> 50 mm Hg and pH> 7.35. If the patient does not have COPD diagnosis at the time of inclusion, it could be included if the diagnosis is confirmed within three months after the exacerbation. Exclusion Criteria: Patients with a pH below 7.35 Patients with intubation criteria Other chronic respiratory diseases (fibrothorax, cystic fibrosis, significant ribcage alterations) Neuromuscular Diseases Significant associated chronic systemic diseases (severe liver disease, chronic renal failure requiring dialysis, severe heart disease and active neoplasia) COPD exacerbation secondary to pulmonary embolism, pneumonia or pneumothorax Patients in active treatment with CPAP or home ventilation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Estirado, PhD
Phone
932483138
Email
97623@parcdesalutmar.cat
Facility Information:
Facility Name
Hospital del Mar (Servei de Pneumología)
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Estirado, PhD
Phone
0034932483138
Email
97623@parcdesalutmar.cat
First Name & Middle Initial & Last Name & Degree
Cristina Estirado, PhD

12. IPD Sharing Statement

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Respiratory Muscle Function in COPD Exacerbations

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